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Regulatory

NVDA

Nvidia has begun shipping alternative products to the China market in limited quantities, according to a recent SEC filing. However, the company has not yet received licenses to ship its restricted chips, including the A800 and H800 models, to China. This development comes amidst increasing regulatory scrutiny and trade tensions between the US and China, potentially affecting Nvidia's business operations and revenue in one of its largest markets.

Portfolio Pulse from Benzinga Newsdesk

February 21, 2024 | 10:16 pm

NVDA

Nvidia has received requests for information from antitrust regulators in France, the European Union, the United Kingdom, and China regarding its GPU sales and supply allocation efforts. This development could indicate regulatory scrutiny over Nvidia's business practices in these regions.

Portfolio Pulse from Benzinga Newsdesk

February 21, 2024 | 10:09 pm

CLPT

ClearPoint Neuro, Inc. (NASDAQ:CLPT) announced FDA clearance and first-in-human cases for its ClearPoint 2.2 Software with integrated Maestro Brain Modeling. Additionally, a validation study for the ClearPoint Maestro Brain Model was published in NeuroImage. The ClearPoint system offers precise navigation for various brain procedures, with the Maestro Brain Model enhancing accuracy and reproducibility in segmentation of brain structures. The first clinical cases using ClearPoint 2.2 were successfully completed, with a full market release expected in the second half of the year.

Portfolio Pulse from Benzinga Newsdesk

February 21, 2024 | 9:54 pm

DDD

3D Systems (NYSE:DDD) has introduced a groundbreaking multi-material, one-piece jetted denture solution, marking a significant advancement in digital dentistry. This solution, which combines aesthetics with durability, is expected to expand the company's addressable dental market significantly, with denture demand projected to exceed $2 billion by 2028. Glidewell, the largest dental lab globally, plans to implement this new denture solution in 2024. The solution has been developed to meet critical patient needs for break-resistance and aesthetics, and is pending 510(k) clearance from the FDA for the second half of 2024.

Portfolio Pulse from Benzinga Newsdesk

February 21, 2024 | 9:51 pm

NVOS

Novo Integrated Sciences, Inc. (NVOS) and its subsidiary, Clinical Consultants International (CCI), have signed a Consulting Services Agreement with Futura Surgicare Pvt Ltd, an India-based surgical product manufacturer. The agreement aims to obtain U.S. FDA 510K approvals for Futura's products and introduce Dolphin Sutures and mesh products to the North American healthcare market. This partnership is expected to bring cost savings and improved care to American patients and healthcare providers.

Portfolio Pulse from Benzinga Newsdesk

February 21, 2024 | 9:48 pm

CYN

Cyngn has been granted an additional 180-day extension, until August 19, 2024, by Nasdaq to maintain its listing on the exchange. This extension provides Cyngn with more time to meet Nasdaq's listing requirements.

Portfolio Pulse from Charles Gross

February 21, 2024 | 9:40 pm

SWSS

Clean Energy Special Situations Corp. (SWSS) received a notice from Nasdaq on February 14, 2024, for not complying with listing standards due to the late filing of its Q3 10-Q report. The company failed to meet the extended deadline of February 12, 2024, leading to a potential suspension of trading of its securities on February 23, 2024. SWSS has requested an appeal and a stay of suspension pending the hearing, but there is no assurance of regaining compliance or preventing the suspension.

Portfolio Pulse from Benzinga Newsdesk

February 21, 2024 | 9:35 pm

CYN

Cyngn Inc. (CYN) has been granted a 180-day extension by Nasdaq to continue its listing on the Nasdaq Capital Market. The company must meet the $1 minimum bid price per share requirement by August 19, 2024, to maintain compliance. Cyngn's CEO, Lior Tal, expressed commitment to resolving the compliance issue and maximizing shareholder value.

Portfolio Pulse from Benzinga Newsdesk

February 21, 2024 | 9:26 pm

NVDA

Nvidia reported a significant decline in data center sales to China in the fourth quarter, attributing the downturn to U.S. government licensing requirements.

Portfolio Pulse from Benzinga Newsdesk

February 21, 2024 | 9:23 pm

BAX

Spectral Medical Inc. has extended its exclusive supply and distribution agreement with Baxter Healthcare Corporation, a subsidiary of Baxter International Inc. (BAX), for the distribution of PMX products in the U.S. and Canada. The extension is for ten years following U.S. FDA marketing authorization for PMX, a device for treating septic shock. Baxter has exercised its option to maintain exclusive distribution rights after Spectral reached a milestone of enrolling 90 patients in its Tigris Trial for PMX.

Portfolio Pulse from Benzinga Newsdesk

February 21, 2024 | 9:02 pm